ClinicalTrials.gg
RecruitingNCT07059962SCALE-PDUpdated Oct 22, 2026

Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)

An observational study in Kidney Disease, Peritoneal Dialysis (PD) and End Stage Kidney Disease (ESRD), sponsored by Bodyport Inc.. Recruiting at 7 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Primary conditionKidney Failure, ChronicRegistry: Kidney DiseasesReclassifiedWhy we changed it
Registry
Kidney Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Kidney Failure, Chronic
Why
  1. The study's listed conditions name Kidney Failure, Chronic, a narrower term within Kidney Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Bodyport Inc. · Observational

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Updated Oct 22, 2026Primary completion movedStudy completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
125
Ages
21 Years and older
Sex
All
01

Study summary

To explore the use of the Bodyport Cardiac Scale in predicting worsening of events due to fluid overload in patients with kidney disease on peritoneal dialysis.

Read the detailed description

The objective of this study is to explore the utility of hemodynamic biomarkers measured by the Bodyport Cardiac Scale in predicting worsening events attributable to fluid overload among those with kidney disease on peritoneal dialysis. The study will explore individual biomarkers, as well as composite biomarker indices, such as the Congestion Index and a novel PD Index.

02

Conditions studied

  • Kidney Disease
  • Peritoneal Dialysis (PD)
  • End Stage Kidney Disease (ESRD)

Browse trials for

Keywords

  • kidney disease
  • peritoneal dialysis
  • fluid overload
  • heart failure
03

In context

Kidney Failure, Chronic Reclassified

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's planned enrollment of 125 is close to the median of 120 across 442 observational studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Bodyport Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Compared within Kidney Failure, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Kidney Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Males and females 21 years of age or older, with end stage kidney disease undergoing peritoneal dialysis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 21 years or older
  2. Able to speak and read English, or able to speak and read Spanish and has a caregiver or family member who speaks English and can provide assistance
  3. Able to stand on two bare feet unassisted
  4. Receiving automated peritoneal dialysis for the treatment of ESKD
  5. Followed on the Vantive Sharesource Remote Patient Management Platform

Exclusion criteria

Exclusion Criteria:

  1. Undergoing or plan to undergo hemodialysis in the next 12 months
  2. Have a of less than 12 months
  3. Are pregnant or plan to become pregnant during the next 12 months
  4. Weigh greater than 375 lbs
  5. Planned kidney transplant within the next 12 months
  6. Have an implanted neurostimulator system
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
125 participants (estimated)
Patient registry
No

Groups and cohorts

  • PD Patients

    Patients with kidney disease on peritoneal dialysis.

    Device: Bodyport Cardiac Scale

Interventions

  • DeviceBodyport Cardiac Scale

    The Bodyport Cardiac Scale captures several physiological signals, which are used to derive multiple biomarkers that reflect a user's hemodynamic and fluid status.

06

What researchers measure

Primary outcomes

  1. Sensitivity Analysis

    Sensitivity for predicting usable PDE \> 0.40 and an alert rate of \< 4.3 alerts per patient-year.

    Time frame: 1 year

Secondary outcomes

  1. Peritoneal Dialysis (PD) Events

    Collection of approximately 40 usable PD Events for model development and validation. These events are defined as urgent, unscheduled clinic visits or emergency department visits or hospital admissions for worsening fluid overload and initiation or intensification of treatment for fluid overload or termination of treatment due to fluid related cause.

    Time frame: 1 year

07

Study locations

7 of 7 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Nov 2027, 26 months after the start.

Of 150 observational studies under Kidney Failure, Chronic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 62. This study's planned 26 months is below that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 19, 2026: primary completion Jun 2026 → Nov 2027 and completion Jun 2026 → Nov 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2025
First posted
Jul 11, 2025
StartActual
Sep 9, 2025
Primary completionEst.
Nov 2027was Jun 2026
CompletionEst.
Nov 2027was Jun 2026
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
3 sites added
Show 3 added (2 Canada, 1 United States)
  • Vanderbilt University Medical Center · Nashville, United States
  • St. Michael's Hospital · Toronto, Canada
  • St. Joseph's Health Centre · Toronto, Canada
Oct 22, 2026
Primary completion
Jun 2026→Nov 2027
Oct 19, 2026
Study completion
Jun 2026→Nov 2027
Oct 19, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Southeastern Clinical Research Institute · Augusta, United StatesContact j•••@scri.care · •••3005→m•••@scri.care · •••3005
Oct 22, 2026
Show all 2 updates
  1. Oct 22, 2026
    3 sites added
    Show 3 added (2 Canada, 1 United States)
    • Vanderbilt University Medical Center · Nashville, United States
    • St. Michael's Hospital · Toronto, Canada
    • St. Joseph's Health Centre · Toronto, Canada
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Southeastern Clinical Research Institute · Augusta, United StatesContact j•••@scri.care · •••3005→m•••@scri.care · •••3005
  2. Oct 19, 2026
    Primary completion Jun 2026→Nov 2027
    Study completion Jun 2026→Nov 2027

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07059962
Lead sponsor
Bodyport Inc.
Responsible party
Sponsor
First posted
Jul 11, 2025
Start date
Sep 9, 2025
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Oct 22, 2026

Study contacts

Corey Centen
Contact
corey@bodyport.com
415-990-5415
Dorothy Kwok
Contact
dorothy@bodyport.com
669-240-3077

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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